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Successful Implementation of HIV Prevention Trials in Peru. The Peruvian CTU. Jorge Sánchez, MD, MPH Javier Lama, MD MPH. Overview. HIV Epidemiology in Peru IMPACTA PERU Clinical Trial Unit Recruitment and retention strategies for MSM implemented in Peruvian Sites IPREX.

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successful implementation of hiv prevention trials in peru

Successful Implementation of HIV Prevention Trials in Peru

The Peruvian CTU

Jorge Sánchez, MD, MPH

Javier Lama, MD MPH

overview
Overview
  • HIV Epidemiology in Peru
  • IMPACTA PERU Clinical Trial Unit
  • Recruitment and retention strategies for MSM implemented in Peruvian Sites
  • IPREX
hiv epidemiology in peru
HIV Epidemiology in Peru
  • 89,000 estimated HIV infected Peruvians
  • Concentrated Epidemic in MSM:
    • Prevalence in General Population: 0.2% among women and 0.6% among men.
    • Prevalence in Female sex workers: 1-2%
    • Prevalence in MSM: 13% overall, over 23% in Lima
  • Predominandtly Clade B. Rare BF recombinants
  • HIV Resistance in 2002: 3.3% in treatment naive; 3.3% in treatment experience.
  • HIV Incidence among MSM in observational cohorts: Lima (3-6.5%); Iquitos (3.2%)
epidemiologia molecular del vih 1
Epidemiologia molecular del VIH-1

Hierholzer et al. AIDS Research and Human Retroviruses, 2002;18:1339-1350

slide8

PERUVIAN CTU

Scientific Steering Committee

HVTN

Working Group

HPTN

Working Group

ACTG

Working Group

CIPRA

Working Group

Universidad de Washington

Gldstone Institute-UCSF

Universidad de Harvard

Community Advisory Board

Administrative

RU

ClinicaL Research

RU

Laboratory

RU

Biostat,

Data Mng

Informatics

RU

Community

Education

RU

clinical research ru
Clinical Research RU
  • INMENSA Lince
  • IMPACTA Miraflores
  • IMPACTA San Miguel
  • ACSA, Iquitos
  • Cayetano Heredia, Pucallpa
  • Equidad, Guayaquil
  • Dos de Mayo Hospital
  • Guillermo Almenara
  • Edgardo Rebagliati
clinical research resource unit
Clinical Research Resource Unit
  • Miraflores CRS (IMPACTA): HPTN, HVTN, ACTG, CIPRA.
  • Lince CRS (INMENSA): HPTN, ACTG, PREP
  • San Miguel CRS (IMPACTA): HPTN, PREP, CIPRA, CFAR/HLA
  • Dos de Mayo CRS: Independent R01
  • Guillermo Almenara Hospital: CPCRA, SMART
  • Edgardo Rebagliati Hospital: CPCRA, SMART
  • Iquitos CRS (ACSA): HPTN, HVTN, PREP
  • Pucallpa CRS (Cayetano Heredia): HPTN
  • Guayaquil CRS (Equidad): CIPRA, PREP
bioestatistics data management and health informatics resource unit
Bioestatistics, Data Management and Health Informatics Resource Unit
  • Data Management Center validated by Parexel
  • Quality Control/Quality Assurance Plan
  • Clinical Research Management Software: development and support
  • Biostatistical support
community education resource unit
Community Education Resource Unit
  • Community Advisory Board
  • Recruitment and Retention
  • Development of Educational Materials
  • HIV/STI Clearinghouse
r r strategies implemented for prevention trials
R&R StrategiesImplementedforPreventionTrials
  • Recruitment strategies
    • Venues mapping - visits and phone calls to past surveillance participants program
    • Community education material development
    • Recruiter incentive and training
  • Retention strategies
    • Patient management software
    • Phone call reminder program
    • Home and work visits
    • Intramural and extramural activities
recruitment strategies
Recruitment strategies
  • Sentinel Surveillance Venues list
  • Venues mapping
  • Peer recruiter leadership
  • Public activities in venues
  • Visits and phone calls to past surveillance participants
  • Free hot line 0800
slide17

Mapped venues in Lima

More than 1000 mapped venues at the end 2006 in Lima

slide19

Venues

Motels

Beaches

Porno Theaters

Streets

Parks

Gay volleyball championship

recruitment strategies cont
Recruitment strategies - cont
  • MSM focus group to generate messages
  • Protocol information in paper (fliers, brochures)
  • Web publishing of Trials info in local gay webs
  • Recruitment of experimented recruiters of Ministry of Health from Peru
  • Program of compensation and incentive to efficient recruiters
slide26

NUESTROS PROGRAMAS

Community Involvement

slide27

Community Development

Workshops

Open Houses

Travestites workshops

Sports

retention strategies
Retention Strategies
  • Clinic information system (CLIS) to manage patient schedule
  • Phone call reminders for each participant visit – managed by CLIS
  • Missed visit activities – home and work visit – alerted by email for CLIS
  • Weekly and bimonthly intramural and extramural activities
clis reminding next visit
CLIS reminding next visit

Screening 1

Visit status

Status in protocol

Email to alert the next visit

Patient advocate

Screened 2 to FU

Phone call

Phone call results

R&R coordinator

Study coordinator

clis alerting a missed visit
CLIS alerting a missed visit

Recruited participant

Screening 1

Contact information

Recruiter

~90%

Screened 2 / all

Phone call Home visit

Status in protocol

Visit status

Screened 2 missed

Contact results

Email alert

Site visit providers

Recruiter

R&R coordinator

Visit window

Study coordinator

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